(56 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or performance studies that would typically be associated with AI/ML-powered devices. The description focuses solely on the intended use of fluid administration during MRI/MRA.
No
The device is used to administer fluids, which is a supportive function during an MRI/MRA examination, not a therapeutic intervention itself.
No
The device is described as assisting in the administration of fluids, which is a therapeutic or interventional function, not a diagnostic one. Its use during an MRI/MRA examination indicates it's part of the procedure, but not performing the diagnosis itself.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes assisting in fluid administration during MRI/MRA, which could potentially involve hardware for controlling fluid flow or monitoring, but this cannot be confirmed without a device description.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- The intended use of this device is to assist in the administration of fluids directly into a patient's vascular system during an MRI/MRA examination. This is a direct interaction with the patient's body for therapeutic or diagnostic imaging purposes, not the analysis of a specimen outside the body.
Therefore, this device falls under the category of a medical device used for patient care and imaging procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.
Product codes
FPA
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA)
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 1997
Dr. Martin R. Prince Chairman Topspins, Incorporated . 1642 Gloucester ----Plymouth, Michigan 48170
Re : K972663 Trade Name: Smart Set Regulatory Class: II Product Code: FPA Dated: July 2, 1997 Received: July 8, 1997
Dear Dr. Prince:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Martin -
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA ation of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeation from the number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Kist Walbert
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K972663 |
|---|---|
| Device Name: | SMARTSET |
| Indications For Use: |
This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
| (Div | BEREATING PLANS PLANS COLLECTION COLORAL CORPORATION CONTROLLER CONSULTANT CONTRACTORS CONCENTRAL |
|---|---|
| Div | |
| and | |
| 510 | 11 . 1 . Step of can been been been former of the |
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
Laituao Cucente
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection of Devision Division
and General Hospital D 510(k) Number